DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 4 and 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Okada et al. (US 2015/0182315) in view of Goto et al. (US 2017/0056140).
Regarding claim 1, Okada teaches a method of producing a dental mill blank and a dental mill blank produced by the method (Pg. 1, Paragraph [0001]). The dental mill blank is formed from an inorganic filler which is subjected to press molding and a polymerizable monomer-containing composition and allowing the polymerizable monomer to polymerize and cure (Pg. 2, Paragraph [0029]). The inorganic filler may be any known inorganic particle which are usable as fillers in dental composite resins, including silica (Pg. 2, Paragraph [0030]). Additionally, the fillers are appropriately selected in order to achieve physical properties that closely resemble that of natural teeth (Pg. 2, Paragraph [0031]). The inorganic fillers are further taught to have an average particle size in the range of 0.001 to 10 microns (1 to 10,000 nm) (Pg. 3, Paragraph [0033]). The inorganic filler may be contained in an amount ranging from 60% by weight to 95% by weight (Pg. 7, Paragraph [0067]; Pg. 9, Paragraph [0086]). The inorganic fillers are mixed with an inorganic pigment in the range of 0.00001 to 1 part by weight (Pg. 6, Paragraph [0060]-[0061]).
Okada is silent with respect to the dental mill blanks satisfying conditions (1) and (2) as required by claim 1.
Okada is additionally silent with respect to the layers in the dental mill blanks satisfying condition (4).
However, the dental mill blanks which satisfy conditions (1) and (2), and further condition (4), appear to be dependent on the methods and materials of forming the dental mill blanks and one of ordinary skill in the art would recognize that a dental mill blank which is formed in a substantially identical method with the same materials would also have substantially identical properties. MPEP 2112.01(I): Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). MPEP 2112.01(II): "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
In particular, the dental mill blanks of claim 1 are formed from an inorganic filler, such as silica, in a content range of 40% to 61% by weight with a average particle size of 30 to 700 nm (Pgs. 2-3, Paragraphs [0021]-[0025]). The inorganic filler may be surface treated and then mixed with an inorganic pigment in a range of 0.07 to 0.100 parts by weight based on 100 parts by mass of the inorganic filler (Pgs. 3-4, Paragraph [0026]-[0029]). The mixture is then combined with a polymerizable monomer and then cured (Pgs. 4-7, Paragraphs [0031]-[0068]). The dental mill blanks may be formed from press molding the compositions (Pg. 2, Paragraph [0021]; Pg. 8, Paragraph [0076]).
As discussed above, Okada teaches the dental mill blanks which are formed from press molding. Additionally, the composition which is press molded includes an inorganic filler in the range of 60% to 95% by weight with particle sizes in the range of 1 nm to 10000 nm (Pg. 3, Paragraph [0034]; Pg. 7, Paragraph [0067]; Pg. 9, Paragraph [0086]). The inorganic particles may be surface treated (Pgs. 7-8, Paragraph [0068]-[0079]). The surface-treated inorganic particles are then mixed with an inorganic pigment in the range of 0.00001 to 1 part by weight (Pg. 6, Paragraph [0060]-[0061]). The mixture is then allowed to contact a polymerizable monomer and then cured (Pgs. 10-14, Paragraphs [0088]-[0150]).
As indicated above, the materials and methods taught by Okada are substantially identical to those described in applicant’s specification. Therefore, one of ordinary skill in the art before the filing of the invention would have found it obvious that the dental mill blanks of Okada and those of applicant’s described invention would have substantially identical properties including satisfying conditions (1) and (2), and further condition (4), required by claim 1.
Okada further teaches the dental mill blanks may be press molded in a layered form (Pg. 7, Paragraphs [0066]-[0067]).
Okada is silent with respect to a different layer from above satisfying condition (3).
Goto teaches dental mill blanks which include a visually identifying portion in order to identify and ascertain the correct number of layers in the dental mill blank (Pg. 1, Paragraphs [0002]-[0007]). The visually identifiable portion may be present through the use of different colors, such as a cervical part color, a dentin color and an enamel color (Pg. 2, Paragraph [0011]). The different colors may be achieved through multiple layers of pastes having different colors (Pg. 2, Paragraph [0011]).
Therefore, it would have been obvious to one of ordinary skill in the art before the filing of the invention to form the dental mill blanks of Okada which have multiple layers formed from pastes having different colors, such as varying the inorganic pigment, in order to achieve a visually identifiable portion as taught by Goto. Additionally, it appears as though condition (3) required by the claim is dependent on the compositions of the dental mill blanks, and specifically the content of the inorganic pigment being in the range of 0.05 to 0.07 parts by weight (Instant Specification, PGPUB, Paragraph [0073]). As discussed above, Okada teaches substantially identical methods and materials including an inorganic pigment range of 0.00001 to 1 part by weight, which overlaps with the required range to satisfy condition (3). Therefore, one of ordinary skill in the art before the filing of the invention would have found it obvious that the dental mill blanks of Okada formed from multiple layers with different inorganic pigment contents would have one layer satisfying conditions (1) and (2) as discussed above and a separate layer which satisfies condition (3).
Regarding claim 4, Okada teaches the dental mill blanks as discussed above with respect to claim 1. As discussed above, the dental mill blanks include inorganic particles in a range of 1 to 10000 nm, which overlaps with the instantly claimed range. MPEP 2144.05: In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Regarding claim 6, Okada teaches the dental mill blanks as discussed above with respect to claim 5. The inorganic pigments may be used in combinations of two kinds or more, which overlaps with the instantly claimed range.
Regarding claim 7, Okada teaches the dental mill blanks as discussed above with respect to claim 1. As discussed above, the dental mill blanks include inorganic particles in a range of 1 to 10000 nm, which overlaps with the instantly claimed range.
In addition to the rejections above, claims 1, 4 and 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Ishino (JP 2017-113224).
Regarding claim 1, Ishino teaches a method for forming a dental mill blank, and the resulting dental mill blanks, wherein the method comprises the steps of laminating a pre-polymerized curable composition to obtain a pre-polymerized laminate consisting of at least two layers; and a step of polymerizing the laminate wherein the curable compositions comprise an inorganic filler and a polymerizable monomer-containing composition (Paragraphs [0008]; [0084]). The inorganic filler may be any known material suitable for dental mill blanks, including silicon dioxide, and the filler may be present in an amount ranging from 40 to 95 mass % (Paragraphs [0029]; [0037]). The fillers may have a particle size ranging from 1 nm to 10 microns (Paragraph [0032]). The compositions further include an inorganic pigment which is present in an amount ranging from 0.00001 to 1 part by weight based on the content of the curable composition and the amount is adjusted in order to achieve a color difference between adjacent layers (Paragraphs [0024]-[0028]).
Ishino is silent with respect to the dental mill blanks satisfying conditions (1) and (2) as required by claim 1.
Ishino is additionally silent with respect to the layers in the dental mill blanks satisfying condition (4).
However, the dental mill blanks which satisfy conditions (1) and (2), and further condition (4), appear to be dependent on the methods and materials of forming the dental mill blanks and one of ordinary skill in the art would recognize that a dental mill blank which is formed in a substantially identical method with the same materials would also have substantially identical properties. MPEP 2112.01(I): Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). MPEP 2112.01(II): "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
In particular, the dental mill blanks of claim 1 are formed from an inorganic filler, such as silica, in a content range of 40% to 61% by weight with a average particle size of 30 to 700 nm (Pgs. 2-3, Paragraphs [0021]-[0025]). The inorganic filler may be surface treated and then mixed with an inorganic pigment in a range of 0.07 to 0.100 parts by weight based on 100 parts by mass of the inorganic filler (Pgs. 3-4, Paragraph [0026]-[0029]). The mixture is then combined with a polymerizable monomer and then cured (Pgs. 4-7, Paragraphs [0031]-[0068]). The dental mill blanks may be formed from press molding the compositions (Pg. 2, Paragraph [0021]; Pg. 8, Paragraph [0076]).
As discussed above, Ishino teaches the dental mill blanks which are formed from stacking two or more polymerizable compositions and subsequently polymerizing the stack which are considered identical to the press molding methods. Additionally, the composition which is press molded includes an inorganic filler in the range of 40% to 95% by weight with particle sizes in the range of 1 nm to 10000 nm (Discussed above). The inorganic particles may be surface treated (Paragraphs [0038]-[0039]). The surface-treated inorganic particles are then mixed with an inorganic pigment in the range of 0.00001 to 1 part by weight (Discussed above). The mixture is then allowed to contact a polymerizable monomer and then cured (Paragraphs [0050]-[0083]).
As indicated above, the materials and methods taught by Ishino are substantially identical to those described in applicant’s specification. Therefore, one of ordinary skill in the art before the filing of the invention would have found it obvious that the dental mill blanks of Ishino and those of applicant’s described invention would have substantially identical properties including satisfying conditions (1) and (2), and further condition (4), required by claim 1.
Ishino is silent with respect to a different layer from above satisfying condition (3).
However, as discussed above, the adjacent layers of the blanks are formed to have a color difference which is affected by the content of the inorganic pigment and the inorganic filler. Furthermore, it appears as though condition (3) required by the claim is dependent on the compositions of the dental mill blanks, and specifically the content of the inorganic pigment being in the range of 0.05 to 0.07 parts by weight (Instant Specification, PGPUB, Paragraph [0073]). As discussed above, Ishino teaches substantially identical methods and materials including an inorganic pigment range of 0.00001 to 1 part by weight, which overlaps with the required range to satisfy condition (3). Therefore, one of ordinary skill in the art before the filing of the invention would have found it obvious that the dental mill blanks of Ishino formed from multiple layers with different inorganic pigment contents would have one layer satisfying conditions (1) and (2) as discussed above and a separate layer which satisfies condition (3).
Regarding claim 4, Ishino teaches the dental mill blanks as discussed above with respect to claim 1. As discussed above, the inorganic filler has a particle size from 1 nm to 10 microns, which overlaps with the claimed range.
Regarding claim 6, Ishino teaches the dental mill blanks as discussed above with respect to claim 1. The inorganic pigments may be used in combinations of two or more, which overlaps with the claimed 3 or more (Paragraph [0027]).
Regarding claim 7, Ishino teaches the dental mill blanks as discussed above with respect to claim 1. As discussed above, the inorganic filler has a particle size from 1 nm to 10 microns, which overlaps with the claimed range.
Response to Arguments
Applicant's arguments filed 04/13/2026 have been fully considered but they are not persuasive.
On pages 4-9, applicant argues that the amendments requiring the two or more layers containing an inorganic pigment in a content range of i) or ii), resulting in the claimed conditions (1)-(4), overcomes the teachings in the rejection based on Okada and Goto as well as the rejection based on Ishino. Specifically, when the two or more layer are within the ranges of i) and ii), each of the four conditions are met. This is exhibited in example 7 of the instant specification which shows a 4-layer configuration exhibiting each of the claimed conditions as required by the claim.
The examiner first recognizes the examples in the instant specification, most notably, examples 5-7 which illustrate at least two layers with examples 6 and 7 exhibiting a four-layer structure. Example 5 appears to illustrate a pigment content range 0.057 parts by mass for the first layer and 0.071 parts by mass. Example 6 appears to illustrate a lowest pigment layer of 0.064 parts by mass and a highest pigment layer of 0.081. Example 7, lastly, appears to illustrate a lowest pigment layer of 0.64 parts by mass and a highest pigment layer of 0.083 parts by mass. As such, each of the examples exhibit at least one layer having a content range of i) and another layer having a content range of ii) as required by the instant claims. It is further noted that each of the examples satisfy each of the conditions (1) through (4). As such, the examiner recognizes that when both of the content ranges of i) and ii) are met, all of the conditions required by the claims appear to be met.
However, upon further consideration of the presented amendments, the claims do not appear to directly require both of the content ranges to be represented by at least one layer. The claim language appears to recite “the two or more layers contain the inorganic pigment in a content range of i) or ii).” While the aim of the claims is to provide one of the layers to have a content range of i) and the at least one other layer has a content range of ii), the language of the claim indicates that both of the at least two layers may have a content range of i) or both of the at least two layers have a content range of ii). Instead, the claimed content ranges, as intended based on the examples, should require wherein at least one of the two or more layers contain the inorganic pigment in a content range of i) and an at least one other layer of the two or more layers contain the inorganic pigment in a content range of ii). The claims should require some type of language similar to this in order to allow the examples provided in the instant specification to be commensurate in scope with the instant claims.
Therefore, the examiner contends that the claims, as currently amended do not overcome the most recent rejections wherein the claims do not instantly require the at least two layers to have different content ranges and the examples appear to require the different content ranges in order to achieve the claimed conditions.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL P DILLON whose telephone number is (571)270-5657. The examiner can normally be reached Mon-Fri; 8 AM to 5 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MARIA V EWALD can be reached at 571-272-8519. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANIEL P DILLON/Examiner, Art Unit 1783
/MARIA V EWALD/Supervisory Patent Examiner, Art Unit 1783
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